A Phase 4 interventional study of iron sulfate in Iron Deficiency Anemia, sponsored by Loma Linda University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Loma Linda University · Phase 4, Interventional, and Treatment
Among 24 studies testing iron in Anemia, Iron-Deficiency — 3 open to participants now, 3 under way, none of them phase 3. Iron · Anemia, Iron-Deficiency.
Among the 24 studies testing iron in Anemia, Iron-Deficiency, this one is the 13th largest by planned enrollment, is one of 2 that started in 2026, is one of 11 in phase 4, and was the 21st registered.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →3 of the 24 studies testing iron in Anemia, Iron-Deficiency are open now, in 2 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 1 Year to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2026.
Median enrollment 107 across the 24 interventional studies. Of the 12 that completed or were terminated, 1 (8%) have results posted.
2 of 24 have an industry lead sponsor. The 10 most frequent:
Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
Loma Linda University has 1 study filed under Anemia, Iron-Deficiency — fewer than ten, so there is no comparison to draw.
1 of the studies testing iron in Anemia, Iron-Deficiency that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06550362Loma Linda UniversityDaily Iron vs Every-other-day Iron for Pediatric Patients With IDA | 2027-05 |
Among the 24 studies testing iron in Anemia, Iron-Deficiency, from their registry updates:
Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. This study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of IDA in pediatric patients.
This is a prospective open-label randomized controlled study. Patients will be randomized into two groups, one group (investigational) will receive oral iron every other day (every 48 hours) and the control group will be prescribed daily oral iron. Data will be collected prospectively including compliance assessment, side effect profile, hemoglobin (CBC), iron stores, hepcidin levels and other monitoring as relevant for best patient care.
At the time of enrollment and following randomization patients will commence treatment with oral iron. Duration of treatment will be 3 months. Laboratory monitoring will also commence at the time of enrollment along with ongoing evaluation of signs and symptoms of anemia, side effects of oral iron therapy, compliance with oral iron therapy. Duration of monitoring will be 6 months.
A medication diary will be provided to all subjects of each group to track their intake of their oral iron supplementation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day.
Drug: iron sulfate
Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day.
Drug: iron sulfate
Oral iron administration
Hemoglobin stabilization
Hemoglobin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if hemoglobin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe.
Time frame: Change between baseline and 3 months post-enrollment
Serum Ferritin stabilization
Serum Ferritin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if Serum Ferritin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe.
Time frame: Change between baseline and 3 months post-enrollment
No study locations are listed for this record.
Plan to share: No — No plan to share IPD with other researchers. Only study results will be shared.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2027, 5 months later.
Of 43 non-industry phase 4 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 35. This study's planned 5 months is below that.
Counting every sponsor, half of 51 studies reached it within 22 months; a quarter within 15 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iron